An exciting contract position has become available for a CQV Engineer, you will be part of a team supporting CQV activities for a new facility. The focus will be executing assigned commissioning, qualification and validation tasks.
- Support the coordination of the integrated CQV Team area team
- Management and generation of weekly CQV activities planning and coordination with utility, calibration and automation teams.
- Mitigation, follow-up, close out and verification of open/closed issues, punch items and non-conformities etc.
- General execution of CQV and DCS/MES software shake-down activities, including EMs, phases, operations and procedures.
- Review and update functional specifications, including EMs, phases, operations, procedures and other software components.
- Accountable for scheduling, tracking, reporting and achieving project the project milestones according to the schedule.
- Understanding and applying industry specific compliance standards/regulations to all CQV activities.
- Leading of risk assessments, root cause analysis, investigations and facilitate/support implementation of corrective and preventive actions.
- Generation and execution of commission test protocols, reports, project change controls and deviations using KNEAT system.
- Proactively highlighting any issues around compliance.
- Participating in internal and external audits and inspections if required.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.